SAFLUTAN 15 micrograms/ml
EYE DROPS, SOLUTION, SINGLE-DOSE CONTAINER
Tafluprost
Read all of this leaflet carefully before you start using this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
- 1. What SAFLUTAN is and what it is used for
- 2. Before you use SAFLUTAN
- 3. How to use SAFLUTAN
- 4. Possible side effects
- 5. How to store SAFLUTAN
- 6. Further information
What Saflutan Is And What It Is Used For
What kind of medicine is it and how does it work?
SAFLUTAN eye drops contain tafluprost, which belongs to a group of medicines called prostaglandin analogues. SAFLUTAN lowers the pressure in the eye. It is used when the pressure in the eye is too high.
What is your medicine for?
SAFLUTAN is used to treat a type of glaucoma called open angle glaucoma and also a condition known as ocular hypertension. Both of these conditions are linked with an increase in the pressure within your eye and eventually they may affect your eyesight.
Before You Use Saflutan
Do not use SAFLUTAN
- if you are allergic (hypersensitive) to tafluprost or any of the other ingredients of SAFLUTAN (see 6. Further information).
Take special care with SAFLUTAN
Please note that SAFLUTAN may have the following effects and that some of them may be permanent:
- SAFLUTAN may increase the length, thickness, colour and/or number of your eyelashes and may cause unusual hair growth on your eyelids.
- SAFLUTAN may cause darkening of the colour of the skin around the eyes. Wipe off any excess solution from the skin. This will reduce the risk of skin darkening.
- SAFLUTAN may change the colour of your iris (the coloured part of your eye). If SAFLUTAN is used in one eye only, the colour of the treated eye may permanently become different from the colour of the other eye.
Tell your doctor
- if you have kidney problems
- if you have liver problems
- if you have asthma
- if you have other eye diseases.
Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription.
If you use other medicines in the eye, leave at least 5 minutes between putting in SAFLUTAN and the other medication.
Pregnancy and breast-feeding
If you may become pregnant, you must use an effective method of birth control during SAFLUTAN therapy. Do not use SAFLUTAN if you are pregnant. You should not use SAFLUTAN if you are breast feeding. Ask your doctor for advice.
Children and adolescents
SAFLUTAN is not recommended for children and adolescents below 18 years due to a lack of data on safety and efficacy.
Driving and using machines
SAFLUTAN has no influence on the ability to drive and use machines. You may find that your vision is blurred for a time just after you put SAFLUTAN in your eye. Do not drive or use any tools or machines until your vision is clear.
How To Use Saflutan
Always use SAFLUTAN exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The usual dose is 1 drop of SAFLUTAN in the eye or eyes, once daily in the evening. Do not instil more drops or use more often than as instructed by your doctor. This may make SAFLUTAN less effective.
Only use SAFLUTAN in both eyes if your doctor told you to.
For use as eye drops only. Do not swallow.
Instructions for use:
When you start a new pouch:
Do not use the single-dose containers if the pouch is broken. Open the pouch along the dashed line. Write down the date you opened the pouch in the space reserved for the date on the pouch.
Every time you use SAFLUTAN:
- 1. Wash your hands.
- 2. Take the strip of containers from the pouch.
- 3. Detach one single-dose container from the strip.
- 4. Put the remaining strip back in the pouch and fold the edge to close the pouch.
- 5. Make sure that the solution is in the bottom part of the single-dose container.
- 6. To open the container, twist off the tab.
- 7. Tilt your head backwards.
- 8. Place the tip of the container close to your eye.
- 9. Pull the lower eyelid downwards and look up.
- 10. Gently squeeze the container and let one drop fall into the space between the lower eyelid and the eye.
- 11. Close your eye for a moment and press the inner corner of the eye with your finger for about one minute. This helps to prevent the eye drop from draining down the tear duct.
- 12. Wipe off any excess solution from the skin around the eye.
If a drop misses your eye, try again.
If your doctor has told you to use drops in both eyes, repeat steps 7 to 12 for your other eye.
The contents of one single-dose container are sufficient for both eyes. Discard the opened container with any remaining contents immediately after use.
If you use other medicines in the eye, leave at least 5 minutes between putting in SAFLUTAN and the other medication.
If you use more SAFLUTAN than you should, it is unlikely to cause you any serious harm. Put in your next dose at the usual time.
If the medicine is accidentally swallowed, please contact a doctor for advice.
If you forget to use SAFLUTAN, use a single drop as soon as you remember, and then go back to your regular routine. Do not use a double dose to make up for a forgotten dose.
Do not stop using SAFLUTAN without asking your doctor. If you stop using SAFLUTAN, the pressure in the eye will increase again. This may cause a permanent injury to your eye.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible Side Effects
Like all medicines, SAFLUTAN can cause side effects, although not everybody gets them. Most side effects are not serious.
Very common side effects
The following may affect more than 1 in 10 people:
Effects on the eye:
- redness of the eye.
Common side effects
The following may affect fewer than 1 in 10 people but more than 1 in 100 people:
Effects on the eye:
- itching of the eye
- irritation in the eye
- eye pain
- dry eye
- sensitivity to light
- blurred vision
- changes in the length, thickness and number of eyelashes
- discolouration of eyelashes
- foreign body sensation in the eye
- watery eyes
- eye discharge
- puffy eyelids
- redness of the eyelids
- change of colour of the skin around the eyes
- change of colour of the iris (may be permanent)
- reduction in the eye’s ability to see details.
Effects on the nervous system:
- headache.
Uncommon side effects
The following may affect fewer than 1 in 100 people but more than 1 in 1000 people:
Effects on the eye:
- tired eyes
- discomfort in the eye
- abnormal sensation in the eye
- swelling of the eye’s surface membranes
- inflammation of the eyelids
- follicles in the surface membranes of the eye
- allergic inflammation or small spotlike areas of inflammation on the surface of the eye
- signs of inflammation inside the eye
- pigmentation of the eye’s surface membranes.
Effects on the skin and tissue under the skin:
- unusual hair growth on eyelids.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How To Store Saflutan
Keep out of the reach and sight of children.
Do not use SAFLUTAN after the expiry date which is stated on the single-dose container, pouch and the outer carton after ‘Exp’. The expiry date refers to the last day of that month.
Store the unopened foil pouches in a refrigerator (2°C – 8°C). Do not open the pouch until you are about to start using the eye drops as unused containers in an open pouch must be discarded 28 days after first opening the pouch.
After opening the foil pouch:
- Keep the single-dose containers in the original foil pouch.
- Do not store above 25 °C
- Discard unused single-dose containers after 28 days from date of first opening of the foil pouch
- Discard an opened single-dose container with any remaining solution immediately after use.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Further Information
What SAFLUTAN contains
The active substance is tafluprost. 1 ml of solution contains 15 micrograms of tafluprost. One single-dose container (0.3 ml) contains 4.5 micrograms of tafluprost.
The other ingredients are glycerol, sodium dihydrogen phosphate dihydrate, disodium edetate, polysorbate 80, and water for injections. Hydrochloric acid and/or sodium hydroxide are added to adjust the pH.
What SAFLUTAN looks like and contents of the pack
SAFLUTAN is a clear, colourless liquid (solution) supplied in single-dose plastic containers, each containing 0.3 ml of solution. Ten single-dose containers are provided in one pouch. SAFLUTAN is supplied in packs containing 30 or 90 single-dose containers. Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Manufacturer:
This medicinal product is authorised in the Member States of the EEA under the following names:
Bulgaria, Czech Republic, Denmark, Estonia, Finland, Iceland, Latvia, Lithuania, Norway, Poland, Slovakia, Sweden: Taflotan
Germany: Taflotan sine
Italy, The Netherlands, Portugal, Romania, Spain, United Kingdom: Saflutan
Austria: Saflutan sine
This leaflet was last approved in April 2010
Logo MSD
denotes Registered Trademark of
PIL.SAF.10.UK.3230 IB-008
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